Somatostatin Normon 6 mg powder and solvent for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Somatostatin NORMON 6 mg Powder and solvent for solution for infusion EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Contents of the leaflet:

1. What Somatostatin NORMON is and what it is used for
2. What you need to know before using Somatostatin NORMON
3. How to use Somatostatin NORMON
4. Possible adverse effects
5. Storage of Somatostatin NORMON
6. Contents of the pack and other information

1. What Somatostatina NORMON is and what it is used for

Somatostatin is a polypeptide hormone composed of fourteen amino acids, primarily found in the hypothalamus and the gastrointestinal tract. Somatostatina NORMON is a synthetic somatostatin identical to the naturally occurring hormone.

Somatostatin inhibits the secretion of numerous hormones such as growth hormone (somatotropin), corticotropin (ACTH), gastrin, insulin, and glucagon, as well as both endocrine and exocrine gastrointestinal and pancreatic secretions. It also reduces gastrointestinal motility and splanchnic blood flow.

Somatostatina NORMON is indicated for:

• Treatment of gastrointestinal bleeding due to rupture of esophageal varices. It should always be used in conjunction with other therapeutic measures (such as sclerotherapy, surgery), complementing but not replacing them.
• Adjunctive treatment of pancreatic fistulas with secretion of at least 500 ml per day.

2. What you need to know before using Somatostatina NORMON

• Do not use Somatostatina NORMON

• If you are allergic (hypersensitive) to the active substance or analogues of somatostatin, or to any of the other components of this medicine (listed in section 6).

• If you are pregnant, or during the breastfeeding period.

• Warnings and precautions

Consult your doctor or pharmacist before starting to use Somatostatina NORMON:

• if you have severe renal impairment (creatinine clearance ≤ 30 ml/min), half the recommended dose will be administered;

• blood glucose levels should be monitored regularly (every 4–6 hours) during treatment with Somatostatina NORMON, as somatostatin exerts inhibitory effects on the release of both glucagon and insulin;

• regular monitoring of renal function and plasma electrolytes should be performed, since Somatostatina NORMON reduces the glomerular filtration rate, urine flow, and plasma sodium levels;

• Somatostatina NORMON inhibits the secretion of other gastrointestinal hormones. Treatment interruption may lead to a rebound effect, especially in patients with fistula; therefore, after healing has occurred, the dose should be reduced by half and administered via infusion over the following 48 hours to prevent such rebound effects;

• if you are insulin-dependent, frequent blood glucose monitoring is required, as somatostatin inhibits insulin release.

• Interaction of Somatostatina NORMON with other medicines:

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

Somatostatin may interact with drugs that influence plasma glucose regulation, plasma renin levels, and blood pressure.

The simultaneous administration of any form of sugar (including glucose or fructose solutions or total parenteral nutrition) may contribute to glucose disturbances and requires close monitoring of blood sugar levels. Insulin administration may occasionally be necessary.

Cases of synergistic effects (additive effects) with cimetidine (a drug used to treat ulcers) have been reported.

Somatostatin prolongs the hypnotic (sedative) effect of barbiturates (drugs with sedative and hypnotic properties) and enhances the action of penteprazole (a drug that reduces gastric acid secretion). Therefore, somatostatin should not be administered concomitantly with these drugs, and ongoing treatments should be discontinued.

• Somatostatina NORMON with food and drinks:

Caution is recommended when administering any form of sugar (see Interaction of Somatostatina NORMON with other medicines).

• Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

Somatostatin, due to its inhibitory effect on growth hormone secretion, is contraindicated during pregnancy, childbirth, and breastfeeding. If administration is required in a breastfeeding mother, breastfeeding must be discontinued.

• Driving and using machines:

Not applicable.

• Somatostatina NORMON contains sodium:

This medicine contains less than 23 mg of sodium (1 mmol) per dose; hence, it is essentially “sodium-free”.

3. How to use Somatostatina NORMON

Follow exactly the administration instructions for Somatostatina NORMON provided by your doctor. Consult your doctor if you have any doubts.

Due to its short half-life of 1 to 2 minutes, Somatostatina NORMON must be administered via continuous and uniform intravenous infusion to maintain plasma levels.

Somatostatina NORMON must be reconstituted with physiological saline immediately before use, and the resulting solution added to the perfusion fluid.

Adults:

The recommended dose is 3.5 micrograms/kg/hour, or typically 6 mg/24 hours for a 75 kg patient, administered as a continuous infusion of 250 micrograms/hour. The infusion rate should be adjusted to 12 hours or 24 hours (for 3 mg and 6 mg, respectively).

Elderly patients:

Dose adjustment is recommended in elderly patients with severe renal impairment (see below, patients with renal impairment).

Children and adolescents:

Adequate clinical studies establishing the safety and efficacy of Somatostatina NORMON in children and adolescents have not been conducted. Therefore, its use is not recommended in this patient population.

Patients with severe renal impairment:

The dose should be reduced to 1.75 micrograms/kg/hour as a continuous infusion and 1.75 micrograms/kg for a loading dose.

Patients with hepatic impairment:

Dose adjustment is not necessary in patients with hepatic impairment alone.

In the treatment of gastrointestinal bleeding and bleeding from esophageal varices, immediately after starting the continuous infusion, a loading dose of 250 micrograms should be administered as a slow intravenous injection over approximately 3 minutes to avoid nausea and sensation of warmth. BLOOD PRESSURE MUST BE CLOSELY MONITORED DURING THE ADMINISTRATION OF THE LOADING DOSE. For this indication, the minimum treatment duration is 48 hours and the maximum duration is 120 hours (5 days). Pancreatic fistulas require a longer treatment period, and administration of an initial loading dose is not necessary. Fistula closure is usually achieved in most patients between 7 and 14 days of treatment, although shorter or longer periods are possible. It should be noted that while somatostatin reduces fistula output and may facilitate skin care around the stoma, it does not increase the number of fistula closures and therefore does not reduce the proportion of patients who ultimately require surgical closure. It also does not replace standard treatment measures. To avoid potential rebound effects after discontinuation, half the dose (1.75 micrograms/kg/hour) should be infused for the following 48 hours.

Patients must be closely monitored after stopping treatment.

Somatostatina treatment should preferably be administered in an intensive care unit.

• If you use more Somatostatina NORMON than you should

No cases of somatostatin overdose have been reported.

If necessary, discontinue the infusion and administer symptomatic treatment. No specific antidote is known.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

• If you forget to use Somatostatina NORMON

Do not administer a double dose to make up for missed doses.

• If you stop using Somatostatina NORMON

Sudden or inappropriate interruption of the infusion may cause a secretory rebound effect.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Somatostatina NORMON may have adverse effects, although not everyone experiences them.

Frequent adverse effects (may affect between 1 and 10 out of every 100 patients) are: abdominal pain, nausea, hyperglycaemia (increased blood glucose), and hot flushes.

Uncommon adverse effects (may affect between 1 and 10 out of every 1,000 patients) are: diarrhoea, decreased blood glucose (hypoglycaemia), decreased heart rate (bradycardia), decreased blood pressure (hypotension), and increased blood pressure (hypertension).

Adverse effects for which there are no data available to determine frequency are: atrioventricular block, arrhythmia, ventricular extrasystoles, vomiting.

At the beginning of the infusion, hypoglycaemia may occur, followed possibly after 2 to 3 hours by an increase in blood glucose due to disturbances in the balance between the counter-regulatory hormones insulin and glucagon. Therefore, blood glucose levels must be monitored regularly and concomitant administration of any type of sugar (including glucose solutions) should be avoided. Insulin administration may be necessary.

Sudden interruption of the infusion may lead to a rebound effect, especially during treatment of patients with fistulas.

During repeated treatments, the risk of hypersensitisation (allergy) to somatostatin cannot be excluded.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

5. Storage of Somatostatina NORMON

Do not store above 25°C.

Keep out of the reach and sight of children.

Stability of reconstituted solutions

After reconstitution, the solution must be protected from light and stored at a temperature not exceeding 25°C for no more than 24 hours.

Expiry date: Do not use Somatostatina NORMON after the expiry date stated on the packaging following the abbreviation "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Somatostatin NORMON:

The active substance is somatostatin. Each vial contains 6 mg of somatostatin (as hydrated acetate). The other component is: mannitol.

Each solvent ampoule contains 1 ml of 0.9% sodium chloride solution.

Presentation of the product and contents of the pack:

Somatostatin NORMON 6 mg is presented as a powder and solvent for solution for infusion. Each pack contains one vial and one solvent ampoule.

Marketing Authorization Holder and Manufacturer:

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This information is intended exclusively for physicians or healthcare professionals:

Treatment should preferably be administered in an intensive care unit.

Patients receiving somatostatin therapy must remain under strict medical supervision. The infusion must be administered slowly and continuously. When a prior intravenous bolus dose of 0.25 mg is required before starting the infusion, this bolus must be administered slowly and continuously (duration exceeding 3 minutes).

Somatostatin blocks the release of glucagon and insulin. Due to this effect, blood glucose levels should be monitored regularly every 4–6 hours during treatment; particular attention should be paid to insulin-dependent patients.

It is recommended to avoid administering the drug concomitantly with carbohydrates requiring insulin for metabolism, and infusion solutions containing glucose or fructose, to prevent disturbances in blood glucose levels. In cases where deemed appropriate, additional doses of insulin may be administered.

Somatostatin inhibits intestinal absorption of certain nutrients. Therefore, parenteral nutrition should be administered concomitantly during prolonged somatostatin treatment.

In all cases, patients should be monitored after discontinuation of treatment.

For 15 minutes following intravenous administration of the medicinal product, the patient should remain in the supine position.

To prepare the loading dose from the 6 mg vial, the 6 mg of lyophilized powder must be reconstituted with 6 ml of physiological saline immediately before use (the solvent ampoule included in this pack contains only 1 ml and not the 6 ml required for reconstitution of the loading dose). No special handling instructions are required beyond those applicable to any injectable formulation.

Take 0.25 ml of the resulting solution, corresponding to 250 micrograms, and administer to the patient by slow intravenous injection over approximately 3 minutes (see section 4.2). If necessary, to facilitate bolus injection over 3 minutes, the 0.25 ml may be diluted with physiological saline to an adequate volume (up to 5 ml).

For reconstitution of the 6 mg dose, the lyophilized powder must be reconstituted with 1 ml of physiological saline immediately before use, and the resulting solution added to the infusion fluid.

Somatostatin is unstable at alkaline pH; therefore, it should not be dissolved in solutions with a pH above 7.5.

OTHER PRESENTATIONS:

Somatostatin NORMON 3 mg Powder and solvent for solution for infusion EFG

Date of the most recent revision of this leaflet: July 2022.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/